This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (NCT00588237), a na phase 2 study. The primary outcome is Overall Objective Response.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00588237 |
| Phase | Phase 2 |
| Condition | Ovarian Cancer, Primary PERITONEUM, Fallopian Tube Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 42 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
People with optimal stage II or III ovarian, primary peritoneal, or fallopian tube cancer were the intended population. The record describes initial treatment and reports enrollment of 42 participants. More detailed eligibility criteria are not reported in the registry record.
Intervention
The study regimen combined intravenous and intraperitoneal paclitaxel, intraperitoneal cisplatin, and intravenous bevacizumab. The registry summary describes reduced cisplatin dosing as part of the rationale, but the dose and treatment schedule are not reported in the registry record.
Comparator
There was no comparison group: the study is listed as single-group, with allocation recorded as not applicable. It therefore does not directly compare the regimen with the two-drug treatment described in the registry summary or with another treatment.
Primary question
The primary endpoint was overall objective response, determined using GOG RECIST criteria, with a timeframe of 2 years. The study’s stated purpose also concerned the safety of combining bevacizumab with the intraperitoneal regimen. The registry record does not report the primary response result.
These features define a treatment study rather than a controlled estimate of comparative benefit. Its single-group structure means that any recorded response or adverse event would describe participants treated in this study; without a comparator, it cannot establish how those outcomes differ from outcomes under another regimen. The registry does not report the criteria used to define optimal disease status, further eligibility details, or the response count. Those omissions limit how precisely the study population and the endpoint result can be interpreted from this record alone.
3. Trial Design
The registry describes a phase II study with a single-group model and no masking. Allocation is marked not applicable, consistent with the absence of a listed comparator arm. Enrollment is recorded as 42, and the study status is completed. The sponsor is Memorial Sloan Kettering Cancer Center. The record lists ovarian cancer, primary peritoneum, and fallopian tube cancer as conditions.
The intervention is paclitaxel, cisplatin, and bevacizumab. The title specifies intravenous and intraperitoneal paclitaxel, intraperitoneal cisplatin, and intravenous bevacizumab. The registry summary frames the regimen as an investigation of adding bevacizumab and lowering cisplatin dose in the setting of initial treatment after surgery. It also describes concerns about treatment side effects and the uncertainty around combining bevacizumab with intraperitoneal therapy. Doses, cycle timing, treatment duration, and rules for modifying or stopping treatment are not reported in the registry record.
The primary outcome is overall objective response, described as a participant count and assessed using GOG RECIST criteria, with a 2-year timeframe. Although the record lists one outcome measure, it lists no analyses, and it does not give a response count or an estimate of response. The registry therefore establishes the planned endpoint but does not permit assessment of the observed endpoint result.
Because the study has no control group, its design can describe what happened among treated participants but cannot isolate the regimen’s effect from other explanations, such as the course of disease or differences in participant characteristics. The registry record does not report randomization, masking procedures beyond NONE, or a statistical analysis plan. Study start and primary completion are recorded as 2006-08 and 2014-11, respectively. The recorded dates do not by themselves establish the length of follow-up for each participant or the timing of individual response assessments.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | All Patients |
|---|---|
| STARTED | 42 |
| COMPLETED | 38 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | All Patients |
|---|---|
| Evaluable for toxicity only | 3 |
| Patien not treated | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | All Patients |
|---|---|---|
| Participants analysed | 42 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 40 |
| Age, Categorical: >=65 years | Participants | 2 |
| Sex: Female, Male: Female | Participants | 42 |
| Sex: Female, Male: Male | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Objective Response, measured over 2 years.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
Overall objective response is the primary endpoint. In general, an objective response endpoint classifies whether a participant’s cancer meets prespecified criteria for a measurable response; the registry specifies GOG RECIST criteria as the assessment standard. The endpoint is expressed as a number of participants, so its central result would be a count of participants meeting the response definition. The registry gives a timeframe of 2 years.
Objective response is used in clinical studies because it provides a structured way to assess changes in measurable disease. Applying stated criteria can make response classification more reproducible than an informal judgment, although the registry record does not detail how assessments were scheduled, who reviewed them, or how missing or indeterminate assessments were handled.
The endpoint does not, on its own, describe every aspect of clinical outcome. A response classification is distinct from duration of response, time to progression, survival, symptoms, and treatment tolerability. Those outcomes should not be inferred from the response endpoint. The registry record does not report a response count, response proportion, uncertainty interval, or statistical test result, so the endpoint’s observed value and precision cannot be evaluated from the recorded information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a primary endpoint but does not report its result. Consequently, there is no recorded objective-response count or estimate to interpret, and no reported confidence interval or test result for that endpoint. The number enrolled is 42, but enrollment alone does not indicate how many participants had an objective response, completed the assessment, or contributed data to the endpoint. Those details are not reported in the registry record.
The study’s single-group design is central to interpretation. A response observed in a treated group can describe outcomes in that group, but it does not provide a direct estimate of the difference between the regimen and another treatment. Without a concurrent comparator, changes cannot be attributed to the regimen by comparison with what would have occurred under an alternative. The record therefore does not support a comparative-effect estimate.
General statistical context: an estimate is more informative when accompanied by a measure of uncertainty. A confidence interval describes a range of values compatible with the data under the method used; it communicates precision as well as the estimate itself. No endpoint confidence interval is reported in the registry record. The absence of such a result means that neither the size nor the precision of the response estimate can be assessed from this record.
The registry states that the study’s purpose included evaluating safety, and it records serious adverse event counts for the all-patients group. Serious events affected 20 of 42 participants at risk. The record also lists other adverse events for 42 of 42 participants at risk. These are descriptive counts, not comparative estimates. The top serious-event terms include obstruction, GI- Small bowel NOS at 9.5%, hypertension at 7.1%, nausea at 7.1%, vasovagal episode at 7.1%, pain - Abdomen NOS at 4.8%, and vomiting at 4.8%. The record does not report whether each event was judged related to treatment, its timing, duration, recurrence, or severity beyond the serious-event classification.
The registry’s planning assumptions describe an illustration based on an observed effect, with equal allocation between two arms and a normal approximation. That hypothetical framework is not the design of this single-group study. The record does not include the resulting planning values or an observed primary effect to use as an input. Such planning illustrations cannot establish the study’s observed power or supply missing outcome evidence.
Overall, the record supports describing the study design, its planned response endpoint, and the adverse-event counts it lists. It does not provide the primary response result or the analysis details needed for a fuller assessment. Any conclusion about comparative efficacy, causal attribution, or the precision of response is therefore not supported by the registry record.
9. Statistical Methods Explained
What does the design allow?
The study is listed as single-group, with no allocation to a comparator and no masking. In general, a single-group study follows participants receiving the intervention and describes outcomes in that group. It can document observed responses and adverse events, but it does not directly estimate how those outcomes compare with an alternative treatment. A comparator helps distinguish differences associated with treatment assignment from differences that may arise from participant characteristics, disease course, or other factors. No comparator is reported for this trial.
The registry identifies the study as phase II. That label describes the phase recorded in the trial record; it does not by itself establish the study’s statistical methods, design justification, or evidential strength. The protocol details and statistical plan are not reported in the registry record, so they should not be inferred from the phase label.
How should the primary endpoint be understood?
Overall objective response is recorded as a participant count, assessed according to GOG RECIST criteria, over a timeframe of 2 years. In general, a binary endpoint assigns each participant to a category such as meeting or not meeting a response definition. A count can then be reported for the category of interest. To interpret such a count fully, readers also need to know the relevant analysis population, how many participants had an evaluable assessment, and how incomplete assessments were treated. These details, along with the actual response count, are not reported in the registry record.
General statistical context: a proportion is often used to place an event count in relation to the number assessed. No response proportion is reported, and none can be inferred from enrollment alone because the number assessed for response is not stated. A confidence interval would help express the precision of an estimate, but no response interval is listed. A point estimate without its uncertainty can give an incomplete picture; in this case, neither is available for the primary endpoint.
What do the planning assumptions represent?
The record describes a sample-size planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the hypothetical effect to detect is a stated fraction of an observed effect. These are planning assumptions, not evidence that this trial randomized participants or included two arms. The actual trial is listed as single-group.
General statistical context: a sample-size calculation asks how many participants a future or planned study might require under specified assumptions about the effect, variability, allocation, and error rates. Changing those assumptions changes the planning result. An illustration based on fractions of an observed effect is conditional on that effect and on the calculation method; it does not describe the precision achieved by the present study. The registry record does not report the planning outputs, a numerical observed effect, or the trial’s own sample-size justification. No planning value can substitute for the unreported response result.
Power is a design property calculated under assumptions about a specified effect and analysis. It is not a measure of whether a completed trial found a result, and a planning illustration is not observed power. Since the trial is single-group while the stated illustration assumes equal allocation between two arms, its assumptions do not mirror the recorded design. The illustration should therefore be read as hypothetical planning context, not as a retrospective assessment of this study’s evidence.
Why do uncertainty and over-dispersion matter generally?
General statistical context: a confidence interval helps show how uncertain an estimated effect is, while a test result addresses compatibility with a specified null model under chosen assumptions. These quantities answer different questions and both depend on the analysis and data. Neither can repair the lack of a comparator in a single-group design. No confidence interval or test result for the primary endpoint is reported in the registry record.
General statistical context: over-dispersion occurs when observed variability is greater than a statistical model expects. If ignored in a model that assumes less variability, uncertainty can be understated and inference can appear more precise than the data warrant. Whether over-dispersion is relevant depends on the outcome and analysis model. The registry record does not report an analysis model for the primary endpoint, so it is not possible to determine whether over-dispersion was assessed or how it would apply.
What is available for analysis review?
The registry lists one outcome measure and zero analyses. That entry does not provide a statistical analysis plan, a model specification, a set of covariates, or a description of adjustments. These methods are not reported in the registry record. The endpoint result itself is also absent, preventing a check of how a reported estimate relates to its count or denominator.
The serious and other adverse-event figures are presented as counts of affected participants and participants at risk, alongside listed serious-event terms and percentages. General statistical context: event counts are descriptive, and their interpretation depends on the population covered, the observation period, event definitions, and the completeness of reporting. The registry supplies an at-risk count for the listed group but does not report safety follow-up duration, person-time, event-level timing, or attribution. The percentages should therefore be read as the registry’s listed figures, not as comparative treatment effects or rates adjusted for exposure time.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when a study tests or estimates several outcomes, subgroups, or treatment contrasts. In general, examining many hypotheses can increase the chance of at least one apparently notable finding by chance. Statistical plans may address this through prespecification, adjustment, or a clear hierarchy of outcomes. The registry lists one outcome measure, overall objective response, but does not report a multiplicity strategy or a statistical analysis plan. It also lists zero analyses. The record therefore does not establish whether additional outcomes or analyses were planned outside the registry entry.
Missing data can affect an endpoint when participants do not have an evaluable assessment. General statistical context: conclusions can depend on how missing observations are handled, especially if missingness is related to health status, treatment discontinuation, or response. The registry does not report the number of participants assessed for the primary endpoint, the number with missing assessments, reasons for missingness, or an imputation or exclusion approach. Enrollment cannot be treated as the endpoint denominator without those details.
The analysis population is also not described. The registry record does not say whether the endpoint was analyzed among all enrolled participants, those who started treatment, those with an evaluable response assessment, or another defined group. These populations answer different questions and may yield different summaries. No conclusions about the analysis denominator or handling of participants who did not complete assessment can be drawn from the recorded information.
For safety, the all-patients group has 42 participants at risk for serious events and 42 at risk for other adverse events. The record gives affected-participant counts, but does not explain missing safety observations, exposure time, or the rules used to include events. Those reporting and analysis details are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| All Patients | 20 | 42 | 47.6% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| All Patients | 42 of 42 |
Most frequent serious adverse event terms
| Event term | Organ system | All Patients |
|---|---|---|
| Obstruction, GI- Small bowel NOS | Gastrointestinal disorders | 4 of 42 |
| Hypertension | Cardiac disorders | 3 of 42 |
| Nausea | Gastrointestinal disorders | 3 of 42 |
| Vasovagal episode | Nervous system disorders | 3 of 42 |
| Pain - Abdomen NOS | General disorders | 2 of 42 |
| Vomiting | Gastrointestinal disorders | 2 of 42 |
| ALT, SGPT | Blood and lymphatic system disorders | 1 of 42 |
| AST, SGOT | Blood and lymphatic system disorders | 1 of 42 |
| Alkaline phosphatase | Metabolism and nutrition disorders | 1 of 42 |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | 1 of 42 |
Most frequent non-serious adverse event terms
| Event term | Organ system | All Patients |
|---|---|---|
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | 33 of 42 |
| Fatigue (asthenia, lethargy, malaise) | General disorders | 30 of 42 |
| Hemoglobin | Blood and lymphatic system disorders | 27 of 42 |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | 24 of 42 |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | 20 of 42 |
| Nausea | Gastrointestinal disorders | 15 of 42 |
| Constipation | Gastrointestinal disorders | 13 of 42 |
| Musculoskeletal/Soft Tissue - Other | Musculoskeletal and connective tissue disorders | 13 of 42 |
| Pain - Abdomen NOS | General disorders | 13 of 42 |
| Vomiting | Gastrointestinal disorders | 11 of 42 |
Serious events with the highest arm-level rate: obstruction, gi- small bowel nos (9.5%), hypertension (7.1%), nausea (7.1%), vasovagal episode (7.1%), pain - abdomen nos (4.8%).
The registry lists serious adverse events for an all-patients group, with 42 participants at risk and 20 affected. It separately lists other adverse events, with 42 participants at risk and 42 affected. These figures describe participants recorded as having events in the registry’s categories; they do not indicate how many individual events occurred, because a participant may have more than one event. The record does not define the observation period for these safety summaries.
The listed serious-event terms include obstruction, GI- Small bowel NOS at 9.5%, hypertension at 7.1%, nausea at 7.1%, vasovagal episode at 7.1%, pain - Abdomen NOS at 4.8%, and vomiting at 4.8%. These percentages are registry-listed values and should not be added together: event categories may overlap within participants, and the record does not specify whether the terms are mutually exclusive.
General statistical context: an adverse event recorded during a study is not, by itself, proof that the treatment caused it. Attribution, timing, duration, recurrence, and exposure-adjusted rates require further information. The registry record does not report these details or a comparison group, so the figures are descriptive and cannot establish comparative safety.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed phase II, single-group study evaluated a regimen of intravenous and intraperitoneal paclitaxel, intraperitoneal cisplatin, and intravenous bevacizumab for initial treatment of the specified cancers. It identifies overall objective response, assessed using GOG RECIST criteria over 2 years, as the primary endpoint. It also records serious and other adverse-event summaries for the all-patients group.
The primary response result is not reported in the registry record. Without a response count, denominator for the endpoint, or uncertainty estimate, the record does not show the observed response level or how precisely it was estimated. The enrollment count does not fill that gap. Nor does the record provide the analyses needed to assess whether any estimate was adjusted or how incomplete response assessments were handled.
The single-group design also limits what the findings could establish even if a response estimate were reported. Descriptive outcomes in one treated group cannot directly show whether outcomes differ from those under another treatment. They also cannot, on their own, separate treatment effects from other influences. No comparative treatment effect is reported.
The adverse-event figures indicate that the registry recorded affected participants in serious and other event categories, with a list of commonly reported serious-event terms and their percentages. They do not establish that the regimen caused those events, provide comparative safety estimates, or describe event timing and exposure-adjusted risk. These interpretations require detail not reported in the registry record.
Accordingly, the record supports a description of the study’s objective, design, endpoint definition, and listed safety counts. It does not support a conclusion about the magnitude or precision of objective response, comparative efficacy, or causal safety effects. Those are distinct questions, and the information needed to answer them is not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically instructive because its primary endpoint and design answer different kinds of questions. Objective response is a defined clinical outcome that can be summarized among participants assessed. A single-group study can describe that outcome, but it cannot directly compare the regimen with another treatment. The distinction between describing outcomes and estimating a comparative effect is essential when interpreting phase II evidence.
The registry’s primary endpoint has a stated assessment standard and timeframe: overall objective response by GOG RECIST criteria at 2 years. Yet the result is absent. This illustrates why an endpoint definition alone is not enough for interpretation. Readers also need the observed count, the relevant denominator, a method for handling incomplete assessments, and a measure of uncertainty. Without those elements, neither the size nor precision of the endpoint estimate is available.
The record also illustrates the difference between a planning calculation and a trial result. Its sample-size assumptions describe an illustration involving two-arm equal allocation, while the recorded study has a single-group design. A planning exercise under hypothetical assumptions does not report the study’s observed effect or demonstrate its power. The underlying outputs and the trial’s own sample-size justification are not reported in the registry record.
Safety reporting requires similar care. Counts of affected participants and listed event percentages are useful descriptive information, but they do not indicate causation or allow a direct comparison in the absence of another group. The record does not report event attribution, timing, or exposure duration. Taken together, these features show why sound statistical interpretation depends not only on a named outcome or a count, but also on design, denominators, uncertainty, and transparent analysis details.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report the primary objective-response count, the number assessed for response, or an uncertainty interval. As a result, the primary endpoint cannot be quantitatively interpreted from the recorded information. The endpoint definition and 2-year timeframe are stated, but response assessment scheduling and handling of unevaluable assessments are not described.
The single-group design has no control arm, so the record cannot support a direct comparison with another regimen. The registry lists no analyses and does not report a statistical analysis plan, sample-size justification for the trial itself, model details, or a multiplicity strategy. The planning assumptions describe a hypothetical equal-allocation comparison, which does not match the recorded single-group design; the planning outputs are not reported.
Participant eligibility details beyond the specified cancer types and optimal stage II or III description are not reported in the registry record. Doses, schedule, treatment duration, adherence, and treatment modification rules are also not reported. The record does not describe the primary endpoint analysis population or missing-data handling.
Safety summaries are limited to the listed affected-participant counts and serious-event terms. The safety observation period, event timing, duration, recurrence, treatment attribution, and exposure-adjusted summaries are not reported. The record does not establish whether events in different categories overlap. These limitations mean that the adverse-event figures should be treated as descriptive registry summaries rather than as complete or comparative estimates of risk.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer — NCT00588237.
- Registry record last updated 2016-01-20; status last verified 2015-12.
- Results first posted 2016-01-20.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT00588237 is a completed phase II, single-group study sponsored by Memorial Sloan Kettering Cancer Center. It enrolled 42 participants and evaluated intravenous and intraperitoneal paclitaxel, intraperitoneal cisplatin, and intravenous bevacizumab for initial treatment of optimal stage II or III ovarian, primary peritoneal, or fallopian tube cancer.
The primary endpoint was overall objective response according to GOG RECIST criteria, with a timeframe of 2 years. The registry record does not report the response result or any analyses. For the all-patients group, it records 20 of 42 participants affected by serious adverse events and 42 of 42 affected by other adverse events. It also lists serious-event terms with percentages. The single-group design, absent endpoint result, and limited analysis and safety details restrict comparative and causal interpretation.